(CBDRA60) to Prevent or Reduce Symptoms of COVID-19 and Prevention of Post-Acute Sequelae of SARS-CoV-2 Infection PASC

NCT04777981 | Unknown

• 1 other identifier: 1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), presents a major threat to human health. SARS-CoV-2 is highly infectious and is associated with extensive morbidity and mortality. Our study shares important features with other clinical trials using supplements or other widely available medications (e.g., Ascorbic Acid, Zinc, Vitamin D, Vitamin C). Our study shares two important elements with these previous studies, including:

1. 1.The use of adaptive and cost-effective study design methods,
2. 2.The testing of prophylactic supplementation using known, natural substances that have demonstrated safety and limited side effects.

Conditions

COVID-19; SAR

Outcome Measures

Primary Outcomes (1)

• Decreased hospitalization

  Number of participants hospitalized and/or requiring repeat emergency room visit from COVID-19 related complications.

  35 days

Secondary Outcomes (1)

• Resolution of COVID-19 symptoms

  35 days

Study Arms (2)

CBDRA60 supplement

EXPERIMENTAL

Daily sublingual tablet containing 30mg Cannabidiol and 30mg Red Algae, a total of 60mg per dose. Participants will take 2 tablets per day, sublingually and with food, taken approximately and at least, 8 hours apart, daily for 28 days. Participants will be mailed a supply of pills by an overnight courier service.

Dietary Supplement: CBDRA60 supplement

Placebo

PLACEBO COMPARATOR

Control subjects will receive daily oral placebo tablets of identical appearance and taste containing no CBDRA60.

Dietary Supplement: Placebo

Interventions

CBDRA60 supplement DIETARY_SUPPLEMENT

CBD is a non-psychotropic cannabinoid that has a broad spectrum of well-established anti-inflammatory and immunomodulatory effects. Red algae (Rhodophyta) are known for their potent anti-viral properties, non-toxicity and for being well tolerated in humans \[15, 16\]. Rhodophyta contain several sulfated polysaccharides that exhibit high antiviral activity against enveloped viruses.,

Also known as: CBDRA60

CBDRA60 supplement

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Baseline drug screen for schedule 1 narcotics
• All participants are required to understand and provide informed consent before any assessment is performed
• Be willing and able to complete an online questionnaire
• Be able to understand and agrees to comply with planned study procedures and be available for all study visits
• Participants who have received the Pfizer or Moderna vaccine are allowed to be enrolled in study if they have a PCR positive test
• Current hospitalization
• Participation in any other COVID-19 trial
• Individuals that are taking antiviral medications
• Baseline lab/drug screen shows consumption of a schedule 1 narcotic
• Prior diagnosis of cancer and currently undergoing radiation, chemotherapy, or immunotherapy; excluding basal cell skin carcinoma
• Participants who have been diagnosed as HIV positive or taking anti-HIV therapy
• Female participants who are pregnant or breastfeeding, lactating, or planning a pregnancy during the trial.
• Female subjects who is/are breastfeeding or plans to breastfeed
• Medical disease or conditions such as high-risk comorbidities such as: diabetes, chronic obstructive pulmonary disease (COPD) or emphysema, history of heart attack or stroke, history of coronary bypass surgery or coronary angioplasty or stent, history of hospitalization for heart failure, etc.
• Demonstrated inability to comply, tell the truth (as defined by PI, study investigator on subjects health condition) with the study procedures

Sponsors & Collaborators

• Anewsha Therapeutics Inc.: lead
• University of Michigan: collaborator
• Biologics Consulting: collaborator

Study Sites (1)

Anewsha Therapeutics / Comco R&D

Hanover, Michigan, 49250, United States

Location

Related Publications (25)

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  PMID: 32109011 BACKGROUND

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

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• Wang R, DeGruttola V, Lei Q, Mayer KH, Redline S, Hazra A, Mora S, Willett WC, Ganmaa D, Manson JE. The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design. Contemp Clin Trials. 2021 Jan;100:106176. doi: 10.1016/j.cct.2020.106176. Epub 2020 Oct 10.

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• Miranda-Massari JR, González MJ, Marcial-Vega VA, Soler JD: A Possible Role for Ascorbic Acid in COVID-19. Journal of Restorative Medicine 2020, 10.

  BACKGROUND

• Bauer SR, Kapoor A, Rath M, Thomas SA. What is the role of supplementation with ascorbic acid, zinc, vitamin D, or N-acetylcysteine for prevention or treatment of COVID-19? Cleve Clin J Med. 2020 Jun 8. doi: 10.3949/ccjm.87a.ccc046. Online ahead of print.

  PMID: 32513807 BACKGROUND

• Skalny AV, Rink L, Ajsuvakova OP, Aschner M, Gritsenko VA, Alekseenko SI, Svistunov AA, Petrakis D, Spandidos DA, Aaseth J, Tsatsakis A, Tinkov AA. Zinc and respiratory tract infections: Perspectives for COVID-19 (Review). Int J Mol Med. 2020 Jul;46(1):17-26. doi: 10.3892/ijmm.2020.4575. Epub 2020 Apr 14.

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• Huestis MA. Human cannabinoid pharmacokinetics. Chem Biodivers. 2007 Aug;4(8):1770-804. doi: 10.1002/cbdv.200790152. No abstract available.

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• Ragab D, Salah Eldin H, Taeimah M, Khattab R, Salem R. The COVID-19 Cytokine Storm; What We Know So Far. Front Immunol. 2020 Jun 16;11:1446. doi: 10.3389/fimmu.2020.01446. eCollection 2020.

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• Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.

  PMID: 32788708 BACKGROUND

• Pellati F, Borgonetti V, Brighenti V, Biagi M, Benvenuti S, Corsi L. Cannabis sativa L. and Nonpsychoactive Cannabinoids: Their Chemistry and Role against Oxidative Stress, Inflammation, and Cancer. Biomed Res Int. 2018 Dec 4;2018:1691428. doi: 10.1155/2018/1691428. eCollection 2018.

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• Ribeiro A, Almeida VI, Costola-de-Souza C, Ferraz-de-Paula V, Pinheiro ML, Vitoretti LB, Gimenes-Junior JA, Akamine AT, Crippa JA, Tavares-de-Lima W, Palermo-Neto J. Cannabidiol improves lung function and inflammation in mice submitted to LPS-induced acute lung injury. Immunopharmacol Immunotoxicol. 2015 Feb;37(1):35-41. doi: 10.3109/08923973.2014.976794. Epub 2014 Oct 30.

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• Wang J, Hajizadeh N, Moore EE, McIntyre RC, Moore PK, Veress LA, Yaffe MB, Moore HB, Barrett CD. Tissue plasminogen activator (tPA) treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): A case series. J Thromb Haemost. 2020 Jul;18(7):1752-1755. doi: 10.1111/jth.14828. Epub 2020 May 11.

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• Nakashima H, Kido Y, Kobayashi N, Motoki Y, Neushul M, Yamamoto N. Antiretroviral activity in a marine red alga: reverse transcriptase inhibition by an aqueous extract of Schizymenia pacifica. J Cancer Res Clin Oncol. 1987;113(5):413-6. doi: 10.1007/BF00390034.

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• Bourgougnon N, Lahaye M, Quemener B, Chermann J, Rimbert M, Cormaci M, Furnari G, Kornprobst J: Annual variation in composition andin vitro anti-HIV-1 activity of the sulfated glucuronogalactan fromSchizymenia dubyi (Rhodophyta, Gigartinales). Journal of applied phycology 1996, 8:155-161

  BACKGROUND

• Bouhlal R, Haslin C, Chermann JC, Colliec-Jouault S, Sinquin C, Simon G, Cerantola S, Riadi H, Bourgougnon N. Antiviral activities of sulfated polysaccharides isolated from Sphaerococcus coronopifolius (Rhodophytha, Gigartinales) and Boergeseniella thuyoides (Rhodophyta, Ceramiales). Mar Drugs. 2011;9(7):1187-1209. doi: 10.3390/md9071187. Epub 2011 Jul 6.

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• Duarte ME, Noseda DG, Noseda MD, Tulio S, Pujol CA, Damonte EB. Inhibitory effect of sulfated galactans from the marine alga Bostrychia montagnei on herpes simplex virus replication in vitro. Phytomedicine. 2001 Jan;8(1):53-8. doi: 10.1078/0944-7113-00007.

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  BACKGROUND

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• Barre A, Damme EJMV, Simplicien M, Benoist H, Rouge P. Man-Specific, GalNAc/T/Tn-Specific and Neu5Ac-Specific Seaweed Lectins as Glycan Probes for the SARS-CoV-2 (COVID-19) Coronavirus. Mar Drugs. 2020 Oct 29;18(11):543. doi: 10.3390/md18110543.

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eleni Stylianou, PHD

  Anewsha Therapeutics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Swartout, MA

CONTACT

7039457066; erin@anewsha.com

Director

CONTACT

chris@anewsha.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double blind, placebo-controlled trial. Patients will be randomized to CBDRA60 supplement or placebo.

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: July 1, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 28, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)